Report Details Unapproved Use of Medtronic, Inc. Spine Surgery Product on Kids
Published: Oct 11, 2012
An expensive and potentially risky back surgery product, not approved for use in children, was used in nearly 10% of pediatric spine surgery cases, prompting concerns about potential complications ranging from cancer to respiratory problems, according to a new research paper. The Journal of the American Medical Association study found that, nationally, an estimated 9.2% of spinal fusion cases in children under the age of 18 used the genetically engineered, bone growth stimulating product known as bone morphogenetic protein, or BMP. "BMP is a powerful molecular growth (agent), and its use in kids is concerning," said Sohail Mirza, a professor of orthopedics at the Dartmouth Medical School. Mirza was not involved in the study. BMP was first approved for use in spine surgery in the United States in 2002 based on research in adults funded by Medtronic, the company that markets the product. The substance stimulates the growth of new bone and can eliminate the need for harvesting a small amount of a patient's own bone for use in creating a spinal fusion. The dominate product on the market is Medtronic's BMP-2, which has generated sales of several hundred millions dollars a year. Much of that has come from off-label uses of the product.